FDA Backs Safety of Transgenic Fish

The first genetically engineered (GE) animal for human consumption—a fast-growing salmon—has come a step closer to the dinner table, with a piece of paperwork posted online on December 22 by the US Food and Drug Administration (FDA).

The FDA’s draft environmental assessment concludes that the fish poses no foreseeable risk to nature. After 60 days of public comment, the FDA may issue a final assessment and approval—at which time AquaBounty, of Maynard, Mass., can begin selling the fish.

However, the draft assessment was dated 4 May, suggesting that the FDA had kept its conclusions under wraps for several months. Advocates on both sides of the issue speculate that political interference may be responsible. “I think it was controversial, and it was an election year,” says Patty Lovera, assistant director of Food and Water Watch, a Washington, D.C., group opposed to GE food animals. An FDA spokeswoman, Morgan Liscinsky, declined to comment on accusations that the process had been politicized, and says it’s possible that the agency could request further studies after the public comment period.

Delays would not shock AquaBounty's CEO, Ron Stotish, whose company has been seeking FDA approval for the fish since 1995. When he was alerted to the decision today, he didn’t initially believe it. “I said, ‘I’ll wait until I see it because I’ve received calls like this before and it never happened,’” he says. The FDA has reviewed more than 50 safety studies, including one that shows the engineered salmon poses no more of an allergic potential than a wild salmon. The engineered Atlantic salmon contains an active growth-hormone gene from a Chinook salmon that allows it to reach market weight in 18 months rather than three years.

Anti-GE groups still have a long list of concerns. Lovera would like to see more studies done on the potential health risks of the salmon, published in peer-reviewed journals and conducted by scientists with no affiliation to AquaBounty. However, it’s not clear where the money to conduct such tests would come from, as federal research funding rarely supports GE animals.

The GE salmon are currently kept within enclosed, inland tanks to prevent the small risk that the nearly sterile females will breed with wild salmon. But Lovera still worries that once the fish are approved, manufacturers will file for permits to keep them within nets in the open ocean in order to lower costs. “This is basically the final step and we think the FDA has given a strong signal that they will accept the fish, and that is a mistake,” she says.

Stotish counters that as part of their application, AquaBounty has promised to not sell the fish to farmers who do not have enclosed, inland tanks. After 17 years and $60 million spent trying to win FDA approval, Stotish is still cautious. ”We are not so foolish to think that this process will suddenly be normal for us,” he says.

This article is reproduced with permission from the magazine Nature. The article was first published on December 22, 2012.